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U.S. Department of Health and Human Services

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Research Project: Continuous Glucose Monitor Performance: Devices for Diabetes Management

Continuous Glucose Monitors (CGM) are implantable class III medical devices that continuously or periodically monitor glucose levels in the fluid (subcutaneous) under the skin of patients with diabetes mellitus for the purpose of improving diabetes management and as an adjunct to blood glucose testing. CGM performance, including device sensitivity and accuracy, depends on many factors, and largely on the chemistry, materials, and design of the sensor. The regulatory assessment of CGM performance relies primarily on pre-clinical animal studies and clinical investigations. However, in vitro performance testing methods that have been proposed to date have not been validated nor standardized. We propose to develop a reliable and accurate test method which would allow in vitro CGM testing under physiologically relevant conditions; and possibly predicting in vivo performance from these data. The effect on CGM performance of potentially interfering electroactive substances, such as pharmacological agents, dietary supplements and artificial sweeteners typically present in the blood of diabetes patients will be assessed in different glycemic regimes.